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  • Digg It - Are Consultants Wasting Your Time with your Business Plans?

    I am about to reveal a business consultants trade secret. Most Business Plans don't work. Business Owners either produce a Plan themselves when the
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    y launch their business, or pay a consultant to write one for them, but it just ends up, unread and unloved on shelf in a cupboard covered in cobwe
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s and dust. If you knew that, would you hire that high price consultant? And can you see why its a trade secret?

    To make a Business Plan work in y
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    our business, you need a Business Management System to drive it. But if the consultant only has a 'Business Plan in a Box' that they want you to bu
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    , because they make more money this way, don't expect them to tell you this. But this is a much harder proposition for the consultant to sell, part
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    cularly to small business owners who are just looking for a quick fix. And a business plan is not a quick fix. To be effective you can't just hand
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    it to someone else to do. It requires you to put in some effort. Not what a consultant wants to tell you. Once owners have prepared their "fill in
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    he blanks" plan, they expect it to transform their business overnight just by its mere existence. But it doesn't, so the plan is left and forgotten
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    .

    Business Plans do work, but you have to make them work. It is not a one-off exercise. If you buy a ‘Business Plan in a Box', you need to underst
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    nd that you are responsible for maintaining the plan. And while a multiple choice answers and a fill in the blanks approach may seem an easy way to
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    go, this won't give you the answers you need. These plans always end up on the bottom shelf. They don't show you how to do your strategic analysis
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    (which is never a fill in the blanks exercise- no matter what someone tells you).

    Business Planning is a real soul searching exercise for the busi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ess owner. You have to be brutally honest with yourself. To be objective, you must get an outsider from your business to force you to be truthful a
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    bout your business strengths and weaknesses! Looking at examples of what others have done can help, but your business will have different strengths
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    and weaknesses and will operate in a different marketplace. And when you finish your plan, does this one-size-fits-all information actually show yo
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    how to make your new plan work.

    This also applies if you use a consultant for your plan. Ask them to show you how to make the plan work. And have
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    the consultant give you at least one review of your performance against your plan six months after the plan has been delivered. While this will co
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    t you extra, this will ensure that your plan does not end up on the bottom shelf- because you know you will be held to account!

    Business Planning
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    is not an easy process. It takes time and commitment. You don't just do it once. This is not what business owners want to hear, and what most consu
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    tants won't tell you, because it might cost them a sale. But the rewards from a well implemented business plan are worth many times your investment


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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